Job Details

Curt Koland Recruiting is seeking candidates with a passion for delivering novel, game-changing technologies and who are committed to improving patient outcomes. Our client is a growth-stage medical device company that has developed, and is now commercial with, intelligently designed and engineered products. Experience in neurovascular, vascular or catheter device is preferred.

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We are looking for candidates currently living in the San Francisco Bay Area with 5 or more years of experience in the Medical Device industry or a closely related field. Candidates must possess either US Work Authorization or US Citizenship. We are not able to accommodate H-1B Visa transfers at this time.

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Job Summary

• We're looking for a highly motivated Project Manager to lead cross-functional initiatives supporting New Product Introduction (NPI), Product Lifecycle Management (PLM), and manufacturing improvement projects.
• This full-time role sits at the center of R&D, Quality, Regulatory, and Manufacturing, driving products from concept through commercialization in a fast-paced, collaborative environment.

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What You'll Do

• Lead cross-functional projects from development through commercial launch
• Build and manage project plans, timelines, deliverables, and risk mitigation strategies
• Drive design transfer activities from R&D into manufacturing
• Coordinate design control activities and maintain compliant product documentation
• Support verification/validation, process qualification, and regulatory documentation
• Partner with suppliers and contract manufacturers to execute project objectives
• Troubleshoot manufacturing challenges using root cause analysis and Six Sigma tools
• Ensure compliance with FDA, ISO 13485, MDR, and global quality standards

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Qualifications

• Bachelor's degree in Engineering or related technical field (Master's preferred)
• 5+ years of project management experience in medical device development and/or manufacturing
• Experience with catheter-based or neurovascular technologies preferred

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Technical Expertise

• Strong knowledge of design controls, risk management, DV/IV, and regulated product development
• Familiarity with FDA regulations, ISO 13485, MDR/MDD, and Quality Management Systems
• Experience with process validation, DOE, SPC, and Six Sigma methodologies
• Working knowledge of CAD tools (SolidWorks preferred)
• Familiarity with EtO sterilization and ISO 10993 is a plus

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What Makes You Successful

• Proven ability to lead cross-functional teams and drive execution
• Strong communicator with excellent organizational skills
• Hands-on problem solver who thrives in dynamic environments
• Comfortable balancing technical detail with strategic project leadership
• Willingness to travel occasionally to suppliers and manufacturing partners